Otezla
These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA (apremilast) tablets, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
f6b1f516-4972-4d82-bced-113e47b41cc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 2023
Manufacturers
FDA
Amgen Inc
DUNS: 039976196
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
apremilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-137
Application NumberNDA205437
Product Classification
M
Marketing Category
C73594
G
Generic Name
apremilast
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2023
FDA Product Classification
INGREDIENTS (12)
APREMILASTActive
Quantity: 30 mg in 1 1
Code: UP7QBP99PN
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
apremilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-369
Application NumberNDA205437
Product Classification
M
Marketing Category
C73594
G
Generic Name
apremilast
Product Specifications
Effective DateJuly 27, 2023
FDA Product Classification
apremilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-485
Application NumberNDA205437
Product Classification
M
Marketing Category
C73594
G
Generic Name
apremilast
Product Specifications
Effective DateJuly 27, 2023
FDA Product Classification